- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622580
A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE)
August 22, 2022 updated by: Hoffmann-La Roche
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
940
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8036
- LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
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Linz, Austria, 4021
- Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde
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Wien, Austria, 1090
- Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
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Wien, Austria, 1140
- Hanusch Krankenhaus; Abteilung für Augenkrankheiten mit Augen-Tagesklinik
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Sofia, Bulgaria, 1309
- Pentagram Eye Hospital (Medical Center "Pentagram")
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Sofia, Bulgaria, 1784
- Specialized Hospital For Active Treatment of Eye Diseases Zora
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Sofia, Bulgaria, 1303
- Medical Center for Eye Health - Focus Ltd
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Sofia, Bulgaria, 1517
- Spec. Ophth. Hospital for Active Treatment- Academic Pashev
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Varna, Bulgaria, 9002
- Ambulatory - Medical Center for Specialized Medical Assistance - "Eye Clinic Sveta Petka" Ltd
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Bordeaux, France, 33000
- Hopital Pellegrin; Ophtalmologie
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Ecully, France, 69130
- Pole Vision Val d'Ouest; Ophtalmologie
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Marseille, France, 13008
- Centre Paradis Monticelli; Ophtalmologie
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Nantes, France, 44093
- CHU Nantes - Hôtel Dieu; Ophthalmology
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Paris, France, 75006
- Centre Odeon; Exploration Ophtalmologique
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Paris, France, 75010
- Hopital Lariboisiere; Ophtalmologie
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Bonn, Germany, 53127
- Universitats-Augenklinik Bonn
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Göttingen, Germany, 37075
- Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde 3.B1.266
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover, Klinik für Augenheilkunde
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Mainz, Germany, 55131
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Augenklinik und Poliklinik
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Münster, Germany, 48145
- Augenabteilung am St. Franziskus-Hospital
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Münster, Germany, 48149
- Universitätsklinikum Münster; Augenheilkunde
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Budapest, Hungary, 1133
- Budapest Retina Associates Kft.
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Debrecen, Hungary, 4032
- Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
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Pécs, Hungary, 7621
- Ganglion Medial Center
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Szeged, Hungary, 6720
- Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
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Szombathely, Hungary, 9700
- Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
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Zalaegerszeg, Hungary, 8900
- Zala Megyei Kórház; SZEMESZET
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Haifa, Israel, 3109601
- Rambam Medical Center; Opthalmology
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Jerusalem, Israel, 9112001
- Hadassah MC; Ophtalmology
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Petach Tikva, Israel, 4941492
- Rabin MC; Ophtalmology
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Rehovot, Israel, 7610001
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky MC; Ophtalmology
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Abruzzo
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Chieti, Abruzzo, Italy, 66100
- Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica
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Lazio
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Roma, Lazio, Italy, 00198
- Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
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Liguria
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Genova, Liguria, Italy, 16132
- UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
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Lombardia
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Milano, Lombardia, Italy, 20100
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
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Milano, Lombardia, Italy, 20132
- Irccs Ospedale San Raffaele;U.O. Oculistica
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Umbria
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Perugia, Umbria, Italy, 06129
- Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
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Aichi, Japan, 480-1195
- Aichi Medical University Hospital
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Aichi, Japan, 460-0008
- Sugita Eye Hospital
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Aichi, Japan, 466-8560
- Nagoya University Hospital
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Aichi, Japan, 467-8602
- Nagoya City University Hospital
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Chiba, Japan, 285-8741
- Toho University Sakura Medical Center
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Fukuoka, Japan, 830-0011
- Kurume University Hospital
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Fukuoka, Japan, 812-0011
- Hayashi Eye Hospital
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Hokkaido, Japan, 060-8648
- Hokkaido University Hospital
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Hokkaido, Japan, 078-8510
- Asahikawa Medical University Hospital
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Hyogo, Japan, 660-8550
- Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
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Ibaraki, Japan, 310-0845
- Kozawa eye hospital and diabetes center
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Kanagawa, Japan, 216-8511
- St. Marianna University Hospital
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Kumamoto, Japan, 860-0027
- Ideta Eye Hospital
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Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Mie, Japan, 514-8507
- Mie University Hospital
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Miyazaki, Japan, 889-1692
- University of Miyazaki Hospital
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Nara, Japan, 634-8522
- Nara Medical University Hospital
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Osaka, Japan, 545-8586
- Osaka City University Hospital
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Osaka, Japan, 530-8480
- Kitano Hospital
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Saitama, Japan, 359-8513
- National Defense Medical College Hospital
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Shiga, Japan, 520-2192
- Shiga University of Medical Science Hospital
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Shizuoka, Japan, 430-8558
- Seirei Hamamatsu General Hospital
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Tokushima, Japan, 770-8503
- Tokushima University Hospital
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Tokyo, Japan, 162-8666
- Tokyo Women's Medical University Hospital
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Tokyo, Japan, 193-0998
- Tokyo Medical University Hachioji Medical Center
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Tokyo, Japan, 181-8611
- Kyorin University Hospital
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Yamaguchi, Japan, 755-8505
- Yamaguchi University Hospital
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Mexico, D.F., Mexico, 01120
- Macula Retina Consultores
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Mexico, D.F., Mexico, 04030
- Hospital de la Ceguera APEC
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Querétaro, Mexico, 76090
- Instituto Mexicano de Oftalmologia I.A.P.
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Mexico CITY (federal District)
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Del. Cuauhtemoc, Mexico CITY (federal District), Mexico, 06760
- Centro Oftalmológico Mira, S.C
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Lima, Peru, 27
- Mácula D&T
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Lima, Peru, 27
- Oftalmosalud Srl
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Lima, Peru, 27
- TG Laser Oftalmica
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Lima, Peru, Lima 33
- Oftalmolaser
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Bielsko-Biala, Poland, 43-309
- Szpital sw. Lukasza
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Bytom, Poland, 41-902
- Szpital Specjalistyczny nr 1; Oddzial Okulistyki
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Gdańsk, Poland, 80-402
- Dobry Wzrok Sp Z O O
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Katowice, Poland, 40-594
- Gabinet Okulistyczny Prof Edward Wylegala
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Krakow, Poland, 31-070
- Centrum Medyczne UNO-MED
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Rybnik, Poland, 44-203
- Optomed Sp. z o.o.
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Rzeszów, Poland, 35-055
- Kliniczny Szpital Wojewodzki nr 1 im. F. Chopina; Klinika Okulistyki
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Wroclaw, Poland, 53-334
- SPEKTRUM Osrodek Okulistyki Klinicznej
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Moscow, Russian Federation, 119435
- FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
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St.Petersburg, Russian Federation, 194044
- Medical Military Academy n.a S.M.Kirov
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Baskortostan
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UFA, Baskortostan, Russian Federation, 450059
- Clinic Optimed
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Trebišov, Slovakia, 075 01
- Nemocnica s poliklinikou Trebišov, a.s.
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Trencin, Slovakia, 911 71
- Fakultna nemocnica Trencin Ocna klinika
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Zilina, Slovakia, 012 07
- Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie
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Albacete, Spain, 02006
- Complejo Hospitalario Universitario Albacete; Servicio de oftalmologia
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Alicante, Spain, 03016
- VISSUM Instituto Oftalmológico de Alicante
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Barcelona, Spain, 08021
- Centro de Oftalmologia Barraquer; Servicio Oftalmologia
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Barcelona, Spain, 08028
- Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
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Barcelona, Spain, 08041
- Hospital de Santa Creu I Sant Pau; Servicio de Oftalmologia
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Madrid, Spain, 28027
- Clinica Universitaria de Navarra; Servicio de Oftalmologia
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LA Coruña
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Santiago de Compostela, LA Coruña, Spain, 15706
- Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
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LAS Palmas
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Las Palmas de Gran Canaria, LAS Palmas, Spain, 35016
- Hospital Universitario de Gran Canaria; Servicio de oftalmologia
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universitaria de Navarra; Servicio de Oftalmologia
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Ankara, Turkey, 06100
- Hacettepe University Medical Faculty; Department of Ophthalmology
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Izmir, Turkey, 35100
- Ege University Medical Faculty; Department of Ophthalmology
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Konya, Turkey, 42130
- Selcuk University Faculty of Medicine; Department Of Ophthalmology
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Arizona
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Mesa, Arizona, United States, 85206
- Barnet Dulaney Perkins Eye Center
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Phoenix, Arizona, United States, 85021
- Arizona Retina and Vitreous Consultants
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Tucson, Arizona, United States, 85704
- Retina Associates Southwest PC
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California
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Campbell, California, United States, 95008
- Retinal Diagnostic Center
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Fresno, California, United States, 93720
- Eye Medical Center
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Oakland, California, United States, 94609
- East Bay Retina Consultants
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Palm Desert, California, United States, 92211
- Southern CA Desert Retina Cons
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Pasadena, California, United States, 91107
- California Eye Specialists Medical group Inc.
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Poway, California, United States, 92064
- Retina Consultants, San Diego
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Redlands, California, United States, 92373
- Retina Consultants of Southern California
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Riverside, California, United States, 92505
- Kaiser Permanente Riverside Medical Center
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Sacramento, California, United States, 95817
- University of California, Davis, Eye Center
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San Francisco, California, United States, 94107
- W Coast Retina Med Group Inc
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Santa Ana, California, United States, 92705
- Orange County Retina Med Group
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Colorado
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Lakewood, Colorado, United States, 80228
- Colorado Retina Associates, PC
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Florida
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Deerfield Beach, Florida, United States, 33064
- Rand Eye
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Palm Beach Gardens, Florida, United States, 33410
- Retina Care Specialists
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Pensacola, Florida, United States, 32503
- Retina Specialty Institute
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Tallahassee, Florida, United States, 32308
- Southern Vitreoretinal Assoc
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Tampa, Florida, United States, 33612
- University of South Florida
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Tampa, Florida, United States, 33609
- Retina Associates of Florida, LLC
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Georgia
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Marietta, Georgia, United States, 30060
- Georgia Retina PC
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Hawaii
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'Aiea, Hawaii, United States, 96701
- Retina Consultants of Hawaii
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Indiana
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Indianapolis, Indiana, United States, 46290
- Midwest Eye Institute
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Iowa
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West Des Moines, Iowa, United States, 50266
- Wolfe Eye Clinic
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Kansas
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Lenexa, Kansas, United States, 66215
- Retina Associates
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Wichita, Kansas, United States, 67214
- Vitreo-Retinal Consultants
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Kentucky
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Lexington, Kentucky, United States, 40509
- Retina Associates of Kentucky
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Paducah, Kentucky, United States, 42001
- Paducah Retinal Center
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Maine
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Portland, Maine, United States, 04101
- Maine Eye Center
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Maryland
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Baltimore, Maryland, United States, 21209
- The Retina Care Center
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Med; Wilmer Eye Inst
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Chevy Chase, Maryland, United States, 20815
- Retina Group of Washington
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Hagerstown, Maryland, United States, 21740
- Cumberland Valley Retina PC
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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Boston, Massachusetts, United States, 02215
- Beetham Eye Institute, Joslin Diabetes Center
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Worcester, Massachusetts, United States, 01605
- Vitreo-Retinal Associates, PC
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Michigan
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Grand Rapids, Michigan, United States, 49546
- Foundation for Vision Research
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Royal Oak, Michigan, United States, 48073
- Assoc Retinal Consultants PC
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Traverse City, Michigan, United States, 49686
- Associated Retinal Consultants, P.C.
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Minnesota
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Edina, Minnesota, United States, 55435
- VitreoRetinal Surgery
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Missouri
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Chesterfield, Missouri, United States, 63017
- Midwest Vision Research Foundation
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Nevada
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Reno, Nevada, United States, 89502
- Sierra Eye Associates
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New Jersey
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Cherry Hill, New Jersey, United States, 08034
- Mid Atlantic Retina - Wills Eye Hospital
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Edison, New Jersey, United States, 08820
- NJ Retina
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Northfield, New Jersey, United States, 08225
- Retinal & Ophthalmic Cons PC
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Teaneck, New Jersey, United States, 07666
- Retina Associates of NJ
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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New York
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Albany, New York, United States, 12206
- Capital Region Retina
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Great Neck, New York, United States, 11021
- Long Is. Vitreoretinal Consult
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Liverpool, New York, United States, 13088
- Retina Vit Surgeons/Central NY
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New York, New York, United States, 10021
- MaculaCare, PLLC
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Shirley, New York, United States, 11967
- Island Retina
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North Carolina
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Asheville, North Carolina, United States, 28803
- Western Carolina Retinal Associate PA
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Charlotte, North Carolina, United States, 28210
- Char Eye Ear &Throat Assoc
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Hickory, North Carolina, United States, 28602
- Graystone Eye
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Southern Pines, North Carolina, United States, 28387
- Carolina Eye Associates
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Ohio
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Cincinnati, Ohio, United States, 45242
- Cincinnati Eye Institute
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Cleveland, Ohio, United States, 44122
- Retina Assoc of Cleveland Inc
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Columbus, Ohio, United States, 43212
- OSU Eye Physicians & Surgeons
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Dublin, Ohio, United States, 43016
- Midwest Retina
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Oklahoma
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Edmond, Oklahoma, United States, 73013
- Retina Vitreous Center
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Oregon
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Portland, Oregon, United States, 97221
- Retina Northwest
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South Dakota
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Rapid City, South Dakota, United States, 57701
- Black Hills Eye Institute
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Tennessee
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Memphis, Tennessee, United States, 38119
- Charles Retina Institute
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Texas
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Abilene, Texas, United States, 79606
- Retina Res Institute of Texas
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Austin, Texas, United States, 78750
- Austin Clinical Research LLC
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Bellaire, Texas, United States, 77401
- Retina Consultants of Texas
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Dallas, Texas, United States, 75231
- Texas Retina Associates
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DeSoto, Texas, United States, 75115
- Retina Specialists
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Harlingen, Texas, United States, 78550
- Valley Retina Institute P.A.
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Houston, Texas, United States, 77025
- Retina & Vitreous of Texas
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San Antonio, Texas, United States, 78240
- Med Center Ophthalmology Assoc
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Tyler, Texas, United States, 75701
- Eye Care Assoc of East Texas
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Willow Park, Texas, United States, 76087
- Strategic Clinical Research Group, LLC
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Utah
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Salt Lake City, Utah, United States, 84107
- Retina Associates of Utah
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Salt Lake City, Utah, United States, 84132
- University of Utah; Division of Gastroenterology/Hepatology
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Vermont
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Burlington, Vermont, United States, 05401
- University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1
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Virginia
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Falls Church, Virginia, United States, 22042
- Emerson Clinical Research Institute
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Lynchburg, Virginia, United States, 24502
- Piedmont Eye Center
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Norfolk, Virginia, United States, 23502
- Wagner Macula & Retina Center
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Washington
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Spokane, Washington, United States, 99204
- Spokane Eye Clinical Research
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University Eye Institute
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Wisconsin
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Madison, Wisconsin, United States, 53792
- University of Wisconsin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
- Hemoglobin A1c (HbA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to undertake all scheduled visits and assessments
- For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion Criteria:
- Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 6 months prior to Day 1 to the study eye
- Prior administration of IVT faricimab in either eye
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A: Faricimab 6 mg Q8W
Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.
|
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
Other Names:
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye.
It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
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Active Comparator: C: Aflibercept 2 mg Q8W
Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.
|
Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
Other Names:
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye.
It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
|
Experimental: B: Faricimab 6 mg PTI
Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections once every 4 weeks (Q4W), 8 weeks (Q8W), 12 weeks (Q12W), or 16 weeks (Q16W) up to Week 96, followed by the final study visit at Week 100.
|
Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.
Other Names:
The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye.
It was administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Time Frame: From Baseline through Week 56
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment.
An unstructured covariance structure was used.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
Invalid BCVA values were excluded.
97.5% CI is a rounding of 97.52% CI.
|
From Baseline through Week 56
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in BCVA in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment.
An unstructured covariance structure was used.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
Invalid BCVA values were excluded.
95% CI is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
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Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best-Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline BCVA (continuous), baseline BCVA (<64 vs. ≥64 letters), and region of enrollment.
An unstructured covariance structure was used.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
BCVA was measured on the ETDRS chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
BCVA was measured on the ETDRS chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
BCVA was measured on the ETDRS chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
BCVA was measured on the ETDRS chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Time Frame: Baseline, average of Weeks 48, 52, and 56
|
BCVA was measured on the ETDRS chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, average of Weeks 48, 52, and 56
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement invisual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters.
The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
Invalid BCVA values were excluded from analysis.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 16, 52, and 96
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 52, and 96
|
Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 16, 52, and 96
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 52, and 96
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 16, 52, and 96
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 52, and 96
|
Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 16, 52, and 96
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 52, and 96
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 16, 52, and 96
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 52, and 96
|
Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 16, 52, and 96
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 52, and 96
|
Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations
Time Frame: Baseline and Week 52
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR).
PDR was defined as an ETDRS DRSS score of ≥61 on the 7-field/4-wide field color fundus photographs assessment by a central reading center.
The weighted percentages of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% CI is a rounding of 95.04% CI.
|
Baseline and Week 52
|
Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations
Time Frame: Baseline and Week 52
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced PDR.
High-risk PDR was defined as an ETDRS DRSS score of ≥71 on the 7-field/4-wide field color fundus photographs assessment by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% CI is a rounding of 95.04% CI.
|
Baseline and Week 52
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population
Time Frame: Week 52
|
Week 52
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population
Time Frame: Week 52
|
Week 52
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population
Time Frame: Week 96
|
Week 96
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population
Time Frame: Week 96
|
Week 96
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Time Frame: From start of PTI (Week 12 or later) until Week 52
|
From start of PTI (Week 12 or later) until Week 52
|
|
Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations
Time Frame: From start of PTI (Week 12 or later) until Week 96
|
From start of PTI (Week 12 or later) until Week 96
|
|
Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Time Frame: From Baseline through Week 56
|
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined).
An unstructured covariance structure was used.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
From Baseline through Week 56
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined).
An unstructured covariance structure was used.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population
Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (<64 vs. ≥64 letters), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined).
An unstructured covariance structure was used.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations
Time Frame: Average of Weeks 48, 52, and 56
|
Absence of diabetic macular edema was defined as achieving a central subfield thickness (CST) of <325 microns in the study eye.
CST was defined as the distance between the internal limiting membrane and Bruch's membrane.
For each participant, an average CST value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met.
The results were summarized as the percentage of participants per treatment arm who met the endpoint.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world).
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Average of Weeks 48, 52, and 56
|
Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye.
Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population
Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Retinal dryness was defined as achieving a central subfield thickness (ILM-BM) of <280 microns.
Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center.
The weighted estimates of the percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100
|
Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
|
Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm).
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
|
Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
|
Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm).
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
|
Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
|
Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population
Time Frame: Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
|
Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm).
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants.
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
95% confidence interval (CI) is a rounding of 95.04% CI.
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Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100
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Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population
Time Frame: Baseline, Weeks 24, 52, and 100
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The NEI VFQ-25 captures a patient's perception of vision-related functioning and quality of life.
The core measure includes 25 items that comprise 11 vision-related subscales and one item on general health.
The composite score ranges from 0 to 100, with higher scores, or a positive change from baseline, indicating better vision-related functioning.
For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment.
An unstructured covariance structure was used.
Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were implicitly imputed by MMRM.
95% CI is a rounding of 95.04% CI.
|
Baseline, Weeks 24, 52, and 100
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Percentage of Participants With at Least One Adverse Event
Time Frame: From first dose of study drug through end of study (up to 2 years)
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This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs.
Investigators sought information on AEs at each contact with the participants.
All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE.
AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation.
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From first dose of study drug through end of study (up to 2 years)
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Percentage of Participants With at Least One Non-Ocular Adverse Event
Time Frame: From first dose of study drug through end of study (up to 2 years)
|
This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs.
Investigators sought information on adverse events (AEs) at each contact with the participants.
All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE.
The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.
|
From first dose of study drug through end of study (up to 2 years)
|
Plasma Concentration of Faricimab Over Time
Time Frame: Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100
|
Faricimab concentration in plasma was determined using a validated immunoassay method.
|
Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100
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Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study
Time Frame: Baseline, Weeks 4, 28, 52, 76, and 100
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Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA).
The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period.
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Baseline, Weeks 4, 28, 52, 76, and 100
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Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale at Week 52, ITT and Treatment-Naive Populations
Time Frame: Baseline and Week 52
|
The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy.
Ocular imaging assessments were made independently by a central reading center.
The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined).
Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively.
Missing data were not imputed.
97.5% confidence interval (CI) is a rounding of 97.52% CI.
|
Baseline and Week 52
|
Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye
Time Frame: From first dose of study drug through end of study (up to 2 years)
|
This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye.
Investigators sought information on AEs at each contact with the participants.
All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE.
Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation.
|
From first dose of study drug through end of study (up to 2 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.
- Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2018
Primary Completion (Actual)
October 20, 2020
Study Completion (Actual)
September 3, 2021
Study Registration Dates
First Submitted
August 1, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
September 16, 2022
Last Update Submitted That Met QC Criteria
August 22, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR40349
- 2017-005104-10 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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